JP2009519784A - System and method for controlling heart valve dimensions - Google Patents

Abstract

  The method according to the present invention first attaches an anchoring component to a first target site of a cardiac tissue component. Next, the locking component is attached to the second target site of the cardiac tissue component. Thereafter, the tension member is coupled to the anchoring component and the tension member is coupled to the locking component. Next, the distance between the first target portion and the second target portion is adjusted by operating the tension member. Subsequently, the locking member is used to secure the tension member in place.

Description

[Cross-reference to related applications]
This application claims priority from US Provisional Application No. 60 / 750,559, filed December 15, 2005, the entirety of which is hereby expressly incorporated herein by reference. It shall be.

  The present invention relates generally to the field of heart valve repair, and more particularly to a system and method for controlling the dimensions of a heart valve.

  In both developed and developing countries, cardiovascular disease accounts for approximately 50% of deaths. In fact, the risk of death due to heart disease is higher than the risk of death due to symptoms of all combined AIDS and various types of cancer. Worldwide, 12 million people die annually due to cardiovascular disease. Cardiovascular disease is the number one cause of death in the United States, killing 950,000 people annually. In addition, the number of people who are forced to decline their disease and quality of life due to cardiovascular disease has become considerable. About 60 million people in the United States alone have some form of heart disease. Thus, there is a great need to advance devices and measures to treat, cure, and recover a wide range of forms of heart disease.

  Normal heart function inherently relies on proper functioning of each of the four valves of the heart that pass blood to the four chambers of the heart. The four chambers of the heart consist of the upper and right chambers, the right and left atria, and the lower and right chambers, the right and left ventricles. Four valves control blood flowing into these chambers, but consist of a tricuspid valve, a mitral valve, a pulmonary valve, and an aortic valve. A heart valve is a complex structure that relies on the interaction of a number of components to open and close the valve. More specifically, the four heart valves consist of a plurality of leaflets or leaflets composed of fibrous tissue, which attach to the heart wall and help control blood flow through the valve. The mitral valve contains two leaflets and the tricuspid valve contains three leaflets. The aortic valve and the pulmonary valve valve each contain three leaflets that are better called “valvular cusps”, but this designation is derived from the half-moon shape of these leaflets.

  The cardiac cycle involves pumping and distributing both oxygenated and deoxygenated blood within the four chambers. During systole, or regular systole of the heart cycle, oxygenated blood with increased oxygen concentration in the lungs enters the left atrium or upper left chamber of the heart. During diastole, or resting phase of the cardiac cycle, the left atrial pressure exceeds the left ventricular pressure, so oxygenated blood flows into the left ventricle through the mitral valve, which is a check valve. Oxygenated blood is pumped into the aorta through the aortic valve by the contraction of the left ventricle and then delivered to the body. When the left ventricle contracts during systole, the mitral valve closes and oxygenated blood is passed to the aorta. Deoxygenated blood returns from the body via the right atrium. Such deoxygenated blood flows into the right ventricle through the tricuspid valve. When the right ventricle contracts, the tricuspid valve closes and deoxygenated blood is pumped through the pulmonary valve. Deoxygenated blood is oxygenated toward the pulmonary vascular bed, and the cardiac cycle up to this point is repeated.

  The cardiac cycle performed by the various components of the heart is a complex and intricate process. Often, a disorder in one of the various components of the heart or a disorder in performing a cardiac cycle causes one or more different types of heart disease. One of the most common symptoms of heart disease is mitral regurgitation. Mitral regurgitation is divided into multiple stages according to severity. When the age exceeds 55 years old, it is about 20% of men and women when taking an echocardiogram. Some mitral regurgitation is seen. Mitral regurgitation or mitral regurgitation is a symptom that allows blood to flow back into the heart because the mitral valve does not close tightly.

  FIG. 1 shows a normal mitral valve 101. As shown in FIG. 1, the mitral valve 101 includes a mitral ring 105, anterior mitral leaflet 110, posterior mitral leaflet 115, chord 120, medial papillary muscle 135, and lateral papillary muscle 140. The term “mitral annulus” refers to the elliptical region of the leaflet attachment that is continuous with the left atrial floor. The mitral annulus 05 includes an anterior mitral ring 125 and a posterior mitral ring 10. The mitral ring 105 has a saddle shape, and the base of the saddle is located at the inside and outside positions. The anterior mitral leaflet 110 is attached to the anterior mitral ring 125, and the posterior mitral leaflet 115 is attached to the posterior mitral ring 130. The region where the anterior mitral leaflet 110 and the posterior mitral leaflet 115 meet is expressed as outer commissure 145 and inner commissure 150.

  In a normal mitral valve, when the atrial pressure exceeds the ventricular pressure, the valve leaflets are released into the ventricle. As ventricular pressure rises, the leaflets meet and close, covering the area of the annulus. Thus, in the view shown in FIG. 1, during diastole, the anterior mitral leaflet 110 and the posterior mitral leaflet 115 are open to allow blood to flow through the mitral valve 101. In contrast, during systole, the anterior mitral leaflet 110 and the posterior mitral leaflet 115 overlap each other to close the mitral valve 101, and blood regurgitation, or blood circulation, flows into the left atrium. To prevent it.

  Like the mitral valve, the function of the atrioventricular valve involves a complex interaction of multiple components such as the leaflets, chordae, and papillary muscles. Failure of one of these components, or one of the complex interaction functions, can result in mitral valve reflux. For example, excessive lobular tissue, inappropriate lobular tissue, or limited lobular movement can cause mitral reflux. Left ventricular overload occurs as a result of prolonged mitral regurgitation, severe mitral regurgitation, or both. Overuse of the left ventricle can lead to left ventricular enlargement or dysfunction, resulting in heart failure. Mitral regurgitation is a progressive disease that can be fatal if not corrected.

  Still the footsteps of surgical treatment of ischemic mitral regurgitation (IMR) are suboptimal clinical outcomes and long-lasting very lethality. While mitral valve repair is preferable to valve replacement for most causative diseases that cause mitral regurgitation, it remains a challenge for patients with IMR symptoms. At present, a typical example of standard mitral repair for IMR disease is annuloplasty with a small ring. Newer repairs have been proposed to address this difficult disease.

  U.S. Pat. No. 7,087,064 issued to Hyde describes prior art for mitral regurgitation treatment, and as a specific example, a ligature that can be placed percutaneously ( ligature). FIG. 2 is a diagram in which the ligature of Patent Document 1 is arranged on the mitral valve. As described in U.S. Pat. No. 6,057,059, ligatures are placed percutaneously into the heart through blood vessels, veins or arteries. After deployment, the ligature is attached to the mitral valve annulus on both sides of the mitral valve. Placing a ligature that is smaller in diameter than that of the mitral annulus acts to squeeze, shape, or contract the periphery of the mitral valve.

  As an alternative to the passive ligature method of Patent Document 1, there is no doubt that there is a test technique using a central trans-annular suture in combination with a septal-lateral annular cinching (SLAC). It shows the effect. SLAC offers potential advantages over the prior art that avoids congestive heart failure while treating cardiac dysfunction. Traditional approaches and devices for mitral valve treatment often resulted in altering the normal function of the valve. For example, mitral regurgitation is treated by fixing the leaflet behind the valve, and thus converting the bilobular valve to a single leaflet valve. As a non-limiting example, annuloplasty with a ring can prevent acute ischemic mitral regurgitation, but annuloplasty also eliminates normal mitral annulus and posterior lobular force dynamics. To do. Annuloplasty using a ring and other similar techniques can cause degradation of the performance of the mitral valve, for example, performance degradation such as loss of flexibility of the annulus and the occurrence of a transvalvular gradient. This type of technique alters or changes the normal function of the mitral valve. On the other hand, SLAC is performed to preserve the physiological force of the mitral valve and mitral leaflet. In addition, SLAC helps maintain physiological mitral annulus tissue morphology for proper functioning.

  One of the recent studies has focused on adopting conventional SLAC procedures for the purpose of treating acute ischemic mitral reflux in the heart of animals and demonstrates the potential benefits offered by SLAC procedures. See T. A. Timek et al., The Journal of Thoracic Cardiovascular Surgery, May 2002, Issue 123 (5), pages 881-888. Research results show that the septal-lateral diameter dimension of the mitral annulus is reduced by an average of 22% (+/− 10%). The conclusion of this study is that dimensional reduction as described above can alleviate acute ischemic mitral regurgitation, while at the same time making mitral annulus and posterior lobular force dynamics nearly normal. Prerequisite for this study is whether SLAC is a simple method of surgical treatment of ischemic mitral reflux, whether it is ancillary to other medical procedures or alone. Yes, to help preserve physiological annulus function and leaflet function.

  Another conventional SLAC technique is disclosed in US Patent Application Publication No. 2005/0143811 (Patent Document 2) issued to Realyvasquez. Discloses performing SLAC using transdermal deployment. FIG. 3 is a diagram showing a conventional apparatus used for performing the SLAC technique disclosed in Patent Document 2. In FIG. The device 50 shown in FIG. 3 is described in Patent Document 2 as being delivered using a percutaneous intravascular catheter that penetrates the septum between the left and right atria. Once the device has been delivered, two wire reinforced stents 52 are deployed and allowed to expand. The front portion of the stent 52 is temporarily attached to the annulus with a plurality of teeth fixed to the wire. The rear is secured to the rear annulus using similar teeth. Once the stent is in place, the anchor delivered in the vessel will re-strengthen the wire at each position for both the front and rear annulus attachment positions.

  The device 50 disclosed in Patent Document 2 includes a ratchet mechanism 60. The ratchet mechanism is activated by the catheter that delivered the device 50. Patent Document 2 describes that the catheter attached to the ratchet mechanism 60 is rotated counterclockwise to bring the ratchet mechanism 60 into an operating state. The rotation of the ratchet mechanism 60 operates to move the two wire reinforced stents 52 toward the center of the device 50. U.S. Patent No. 6,057,059 indicates that reducing the distance between two wire-reinforced stents 42 attached to both the front and rear annulus helps to achieve the effect of a septal-side annulus tightening procedure. Disclosure.

U.S. Patent No. 7,087,064 US Patent Application Publication No. 2005/0143811

  All of the prior art devices are suitable for their intended purpose, but have a number of deficiencies, and include intervening cardiologists, cardiovascular surgeons, and patients on whom such doctors operate. You are not meeting your requirements. Clearly, there is still a need for devices and associated techniques that minimize open blood for the purpose of correcting defective heart valves. In particular, for the purpose of limiting the septal-lateral diameter distance of the atrioventricular valve, there is a need for a device that minimizes blood viewing and the associated techniques. In addition, devices that minimize open blood and the associated techniques must be able to be implemented in the beating heart. It is often desirable to provide a device that can limit the septal-lateral diameter of the atrioventricular valve, which can be performed in a variety of ways, including thoracoscopic endoscopy and percutaneous surgery.

  Thus, it would be advantageous to provide an apparatus and method that improves valve performance.

  Furthermore, it would be advantageous to provide an apparatus and method for limiting the size of a heart valve.

  It would also be advantageous to provide an apparatus and method for correcting mitral regurgitation by limiting the diameter of the beating heart valve.

  In addition, it would be advantageous to provide an apparatus and method for limiting the diameter of the heart valve of a beating heart that is implemented in a manner that minimizes open blood.

  Furthermore, it is advantageous to provide a device that is delivered from the outside of the heart using a long arm or steerable needle for the purpose of limiting the diameter of the heart valve of the beating heart.

  In addition, it would be advantageous to provide a device that can reduce the septal-lateral diameter of the beating heart atrioventricular valve.

  Furthermore, it would be advantageous to provide a device that can reduce the diameter of the heart valve over a longer period of time.

  There is also a method for reducing the size of a heart valve that allows easy access to components used in previously performed surgery, allowing the physician to further limit the size of the heart valve at a later date. It is advantageous to provide.

  In addition, it would be advantageous to provide a method for reducing the size of a heart valve that allows the size reduction procedure to be repeated over a longer period of time.

  Furthermore, it would be advantageous to provide an apparatus and method that improves the tissue morphology of a beating heart valve without altering the physiological force dynamics of the heart valve.

  The present invention describes a method and apparatus for controlling the dimensions of a heart valve. Exemplary embodiments of the present invention present a method for improving the tissue morphology of a heart valve. The method first includes the step of attaching an anchoring component to a first target site on the cardiac tissue component. Next, a locking component is attached to a second target site on the cardiac tissue component. Thereafter, the tension member is coupled to the anchoring component and then the tension member is coupled to the locking component. Next, the distance between the 1st target part and the 2nd target part is adjusted by operating a tension member. Subsequently, the tension member is secured in place using the locking component.

  The above objects, features and advantages of the present invention and other objects, features and advantages will become clearer when the subsequent specification is read in conjunction with the accompanying drawings.

  The present invention addresses the shortcomings of the prior art by providing a minimally open device and method aimed at improving valve tissue morphology. The medical devices and methods that improve the valve tissue morphology disclosed herein allow the distance between two target sites inside a heart valve to be reduced. By reducing the distance between the two target sites inside the heart valve, valve performance can be improved and / or modified.

  Exemplary embodiments of the present invention provide a method for improving valve tissue morphology. The method first includes the step of attaching an anchoring component to a first target site on the cardiac tissue component. Next, a locking component is attached to a second target site on the cardiac tissue component. Thereafter, the tension member is coupled to the anchoring component and then the tension member is coupled to the locking component. Next, the distance between the 1st target part and the 2nd target part is adjusted by operating a tension member. Subsequently, the tension member is secured in place using the locking component.

  While exemplary embodiments of methods for improving valve tissue morphology can be utilized to treat mitral regurgitation, in some cases mitral regurgitation can be corrected. For example, but not necessarily, it is possible to reduce the distance between the first target site and the second target site so that the septal-lateral diameter of the mitral valve Can be reduced. In this way, reducing the septal-lateral diameter of the mitral valve allows it to overlap with the mitral leaflets during systole, thereby assisting in mitral valve performance. Can do. In addition, reducing the septal-lateral diameter can prevent blood from circulating from the left ventricle to the left atrium during systole or help to alleviate such reflux.

  In addition, in order to improve the tissue morphology of the mitral valve, the methods and apparatus that the present invention can provide can be used to improve the performance of various heart valves other than the mitral valve. An exemplary embodiment of a method for improving valve tissue morphology can be utilized to treat aortic valve regurgitation and possibly correct aortic regurgitation. Variations of the method for improving valve tissue morphology can be utilized to improve the performance of pulmonary and tricuspid valves.

  The method for improving valve tissue morphology according to the present invention is a minimally invasive procedure that can be performed on a beating heart. Furthermore, the method for improving the tissue morphology of the valve according to the present invention is performed by various procedures or combinations of these procedures including endoscopic deployment using a thoracoscope, intravascular delivery deployment, percutaneous deployment, and the like. One of ordinary skill in the art should recognize that the embodiments of the method for improving valve tissue morphology and the devices associated therewith described herein are exemplary and are presented only as representative examples. It is.

  In an exemplary embodiment of the invention, a tightening device is provided that includes an anchoring component that is provided with a proximal end and a distal end. A proximal end of the anchoring component is provided with a fitting connected to the heart tissue component. The locking component is also provided with a fitting connected to the cardiac tissue component. The clamping device also includes a tension member. The anchoring component can be placed at a first target site on the heart tissue component, and the locking component can be placed at a second target site on the heart tissue component. And the tension member is connected to both the anchoring component and the locking component. The tension member is actuated to adjust the distance between the first target site and the second target site and then secured by the locking component.

  In the illustrated embodiment, the pulling member is pulled to actuate the pulling member to adjust the distance in a manner that reduces the distance between the first target site and the second target site. For example, but not limited to, if the physician pulls the tension member, the distance can be reduced and the tension member can be secured in place.

  An exemplary embodiment of a clamping device has one or more anchoring components, locking components, and tension members. These component materials are utilized in the method of improving the tissue morphology of the valve according to the present invention. In the illustrated embodiment, the various components of the clamping device are constructed from a biocompatible material. Specific examples of biocompatible materials include, but are not limited to, biocompatible metals or biocompatible polymers. Those skilled in the art should recognize that the clamping device may be constructed from a wide range of biocompatible materials without departing from the scope of the present invention.

  An anchoring component is a device that can be attached to tissue. In the illustrated embodiment, the anchoring component has a proximal end and a distal end. The term “proximal” is used herein to describe that a location is relatively close to another location, including a range of a plurality of nearby locations, where one location is another Including directly adjacent or abutting a position. The term “distal” is used herein to describe that one location is relatively far from another location. Accordingly, in this specification, the terms "proximal" and "distal" are used to refer to spatial relationships and are used to describe positions upstream or downstream of blood flow. Not.

  In an exemplary embodiment, the proximal end of the anchoring component can be capable of engaging tissue. For example, and without limitation, the proximal end face or bar of the anchoring component is at an angle to the body of the anchoring component. Depending on the angle of the face or bar, the face or bar can have a joint or grip for tissue components. In an alternative embodiment, the anchoring component has an umbrella-shaped proximal end that can pierce the tissue surface. Another embodiment is an anchoring component having legs that can be implanted in a tissue surface. One skilled in the art should recognize that the proximal end of the anchoring component may be substituted with various component materials that can be attached to the tissue surface.

  In the illustrated embodiment, the central portion of the fixation system is a rod, wire, or many other suitable elongated members. The distal side of the anchoring component is an engagement member or engagement surface. Such engagement members are designed to couple with a tension member or rod. Preferred embodiments of the connecting member are loops, screw faces, hooks, clamps, coupling openings, or many other suitable components. The anchoring component may be delivered intravascularly using a catheter, or it may be delivered through an entry window in the heart chamber using a long arm delivery device or a steerable needle. One skilled in the art should recognize that the apparatus and instruments used to perform each method of the present invention may vary from embodiment to embodiment. For example, those skilled in the art will appreciate that long arm devices can be substituted with many different types of devices that can deliver a member with minimal open blood.

  FIG. 4A is a diagram illustrating an exemplary embodiment of an anchoring component or anchoring device 400A according to the present invention. The anchoring component 400A shown in FIG. 4A has a mounting member 405 at its proximal end. The attachment member 405 can engage and pierce the tissue component. In the exemplary embodiment shown in FIG. 4A, the attachment member 405 is an umbrella structure. A central portion of the fixing device 400 </ b> A is a rod member 410.

  The fixation device 400A shown in FIG. 4A also has an engagement member 415 at its distal end. The engagement member 415 can connect a tension member or other medium and serve as a terminal end portion or fix the tension member or other medium. As shown in the exemplary embodiment of FIG. 4A, the engagement member 415 may be a pigtail shaped member. The reason why the pigtail shaped member is advantageous is that the engagement member 415 can be deployed after the pigtail shaped member is inserted through the tissue component. In the illustrated embodiment, the engagement member 415 is inserted into the tissue component in a substantially flat configuration and deployed in a pigtail shape. One skilled in the art should recognize that the engagement member 415 may have a variety of configurations without departing from the scope of the present invention.

  FIG. 4B shows an alternative embodiment anchoring component 400B according to the present invention. An anchoring component 400B of the alternative embodiment shown in FIG. 4B has a mounting member 420, which is a rod-shaped member, at its proximal end. This rod-shaped attachment member 420 is joined to the tissue surface. The exemplary embodiment of anchoring component 400B has two engagement members 430, 435. The engagement members 430, 435 may be pigtail shaped members that can be coupled to the tension members as shown in FIG. 4B. Without limitation, in one example, once the engagement member 430 is positioned within the heart chamber, the engagement member 430 is coupled to a tension member and the engagement member 435 is coupled to a tension member different from the tension member. Those skilled in the art will appreciate that the two embodiments of anchoring components 400A, 400B shown in FIGS. 4A and 4B are presented as representative examples, and that the anchoring components may be implemented in various alternative devices. Should be recognized.

  FIG. 5 shows an exemplary embodiment of the anchoring component engagement member 505 according to the present invention prior to deployment. The engagement member 505 shown in FIG. 5 can be delivered in a substantially flat shape. An exemplary embodiment of the engagement member 505 may be delivered in a steerable needle or other suitable delivery device. Thus, the engagement member 505 can pierce the tissue component in a substantially flat shape. Once the engagement member 505 has been pierced through the tissue component, the engagement member 505 may be deployed. For example, without limitation, the posterior mitral annulus is pierced through the engagement member 505 from the left ventricle into the left atrium. In the illustrated embodiment, once the engagement member 505 is located in the left atrium, the engagement member 505 is pushed out of the lumen to form a pigtail shaped member. This pigtail-shaped member has a structure necessary for attaching the tension member to the engaging member 505 later.

  FIG. 6A is a diagram illustrating an exemplary embodiment of a locking component 605 according to an exemplary embodiment of the present invention. In the illustrated embodiment, the locking component 605 engages the outer surface of the heart or engages the cartilage at a triangular site or other area. The piercing component that allows engagement of the locking component 605 is a hook, an umbrella, a mating surface, a plurality of expandable legs, or other suitable component. The locking component 605 has a locking system that secures the tension member 610, which prevents movement of the tension member 610 when it is engaged with the tension member 610 and limits the diameter of the valve. Is good. In the exemplary embodiment shown in FIG. 6A, the locking component 605 has a locking system 630 that constitutes a pin compression system. As shown, the pins of the locking system 630 may be movably positioned to secure the tension member 610 and to release such fixation.

  In the illustrated embodiment, the locking component 605 is attached at a number of suitable target sites on the cardiac tissue component. For example, but not by way of limitation, in one embodiment, the locking component 605 is on a mitral annulus that is substantially opposite to where the anchoring component is attached to the mitral annulus. Attached to the target site. The locking component 605 has a piercing component, eg, 620, 625, that pierces the tissue component, and the piercing component secures the locking component 605 to the tissue component. In the exemplary embodiment shown in FIG. 6A, the piercing components 620, 625 pierce the left atrial wall near the anterior mitral annulus and adjacent to the aortic wall.

  The locking component 605 has a conduit through which the tension member 610 can pass. In the exemplary embodiment, tension member 610 is threaded into locking component 605 and enters the left atrium. In this exemplary embodiment, the tension member 610 has an engagement distal end that is coupled to the engagement member 415 of the anchoring component 400A (FIG. 4A). Once the tension member 610 is coupled to the anchoring component 400A, the tension member 610 is advanced so that the distance between the anchoring component 400A (FIG. 4A) and the locking component 605 is reduced. After reducing this distance by the desired amount, the locking system 630 of the locking component 605 secures the tension member 610 in place. In the illustrated embodiment, a surgeon performing the method of improving valve configuration according to the present invention pulls the tension member 610 from a position outside the patient's body and secures the tension member 610 in place with the locking component 605.

  In the illustrated embodiment, the locking component 605 can be unlocked. Accordingly, if it is desired to later change the distance between the locking component 605 and the anchoring component 400A, the tension member 610 is unlocked by the locking component 605. In a non-limiting example, the tension member 610 is advanced to further reduce the distance between the locking component 605 and the anchoring component 400A and re-secure the tension member in place.

  FIG. 6B is a diagram illustrating a modified embodiment of the locking component 605 according to an exemplary embodiment of the present invention. As shown in FIG. 6B, an alternative embodiment of the locking component 605 incorporates a screw component 615 that advances the tension member 610. The surgeon thereby advances the screw component 615 from a position outside the patient's body to advance the tension member and reduce the distance between the locking component 605 and the anchoring component 400A (FIG. 4A). Can do. When the tension member 610 is advanced a desired distance, the screw is released. The stationary screw component 615 then locks and maintains the tension member 610. In addition, the screw component 615 may be contacted again to further advance the tension member 610 and lock the tension member 610 in a new position.

  FIG. 7 is a diagram illustrating an exemplary embodiment of an anchoring component 705 of the present invention. In the exemplary implementation shown in FIG. 7, an anchoring component 705 is implanted through the posterior mitral annulus 720. For example, and without limitation, anchoring component 705 is delivered intravascularly using a catheter. Further, the anchoring component 705 is delivered in compressed form and later deployed once in place. In a non-limiting example, anchoring component 705 is delivered into the left ventricle. Next, anchoring component 705 is inserted into the posterior mitral annulus 720 from the left ventricle at the target site. Accordingly, the engagement member 710 of the anchoring component 705 is pierced through the posterior mitral annulus 720 at the target site. Once the engagement member 710 pierces the posterior mitral annulus and enters the left atrium 730, the attachment member 715 of the anchoring component 705 is attached to the posterior mitral annulus 720. In this manner, anchoring component 705 is hooked over posterior mitral annulus 720 and engaging component 710 projects into left atrium 730.

  In an alternative embodiment of the method for improving valve morphology, anchoring component 705 is delivered through left atrium 730. In a non-limiting example, anchoring component 705 is attached to the catheter and placed percutaneously in left atrium 730. After the anchoring component 705 is introduced into the left atrium 730, the anchoring component 705 is pierced through the posterior mitral annulus 720 at the target site. In the illustrated embodiment, attachment member 715 of anchoring component 705 is pierced through posterior mitral annulus 720 at the target site and protrudes into the left ventricle. In this manner, anchoring component 705 is hooked over posterior mitral annulus 720 at the target site.

  Those skilled in the art should recognize that the exemplary embodiment shown in FIG. 7 is merely an example of implantation of an anchoring component according to the present invention. For example, without limitation, with respect to the posterior side of the mitral valve, the anchoring component can be placed anywhere on the posterior mitral annulus or on the proximal myocardium. With respect to the anterior side of the mitral valve, the anchoring component can be placed anywhere on the anterior mitral annulus, on the myocardium adjacent to it, or on the fibrous triangular region adjacent to the anterior mitral annulus Is possible.

  FIG. 8 is a diagram illustrating an exemplary embodiment of a clamping device 800 according to an exemplary embodiment of the present invention. The exemplary embodiment of the clamping device 800 shown in FIG. 8 implants two pairs of anchoring components and locking components. The view shown in FIG. 8 shows an anchoring component engagement member 805 protruding into the left atrium 810. The locking component 815 can be positioned at various target sites, such positioning including attachment to the wall of the left atrium 810 near the aortic valve. As shown in FIG. 8, in the exemplary embodiment, locking component 815 is located outside the left atrium. The lock component 815 can receive the tension member 820 through a conduit in the lock component 815. Once the tensioning device 820 is passed through the locking component 815 and into the left atrium 815, the engagement end 825 of the tensioning member 820 is coupled to the engagement member 805 of the anchoring component. After the tension member 820 and the anchoring component 820 are coupled, the tension member 820 is pulled to reduce the septal-lateral diameter of the mitral valve 830. In the exemplary embodiment shown in FIG. 8, such a reduction process is performed outside the heart. Those skilled in the art will recognize that each procedure is performed from outside the heart with a number of techniques that minimize open blood, including placement by thoracoscopic surgery, placement by intravascular delivery, and placement by percutaneous delivery. can do. In addition, in alternative embodiments, the method steps of the present invention may be performed via a remote device. For example, but not limited to, a surgeon can use a remote device to adjust the tension member 820 and reduce the septal-side diameter of the mitral valve 830.

  For example, and without limitation, the tension member 820 may extend through a long arm device outside the patient's body. Thus, the surgeon can pull the tension member 820 outside the patient's body, thereby reducing the septal-side diameter of the mitral valve 830.

  One skilled in the art should recognize that one or several sets of locking and anchoring components connected by a tension member can be implemented within an atrioventricular valve in accordance with the present invention. In some implementations, only one set of locking and anchoring components are implemented that are connected by a tension member. Generally, a range of 2 to 10 sets of locking and anchoring components connected by a tension member are implemented in the atrioventricular valve.

  As shown in FIG. 8, the mitral valve 830 has two sets of locking and anchoring components that are connected by two tension members. The second set is implemented on the opposite side of the mitral valve 830. The engagement member 835 is positioned on the opposite side of the engagement member 805 of the rear mitral valve annulus. As with the other set, the lock component 840 is threaded through a tension member 845 that is coupled to the engagement member 835. In the exemplary embodiment shown in FIG. 8, the two sets of locking and anchoring components are positioned such that the tension members 820, 845 extend sufficiently parallel to each other. This configuration helps to maintain the symmetry of the mitral valve 830 when the diameter of the mitral valve 830 is reduced. Similar to the first tension member 820, the second tension member 845 can be extended out of the patient's body to allow the surgeon to reduce the septal-side diameter by pulling the extracorporeal portion of the tension member. Once both tension members 820, 845 have been pulled sufficiently to reduce the septal-side diameter of the mitral valve 830, the tension members 820, 845 are secured by their respective locking components 815, 849. Locking the tension members 820, 845 ensures that the mitral valve 830 is maintained at the desired dimensions.

  According to an exemplary embodiment of the present invention, the locking component can be unlocked. In this way it is possible to readjust the dimensions of the heart valve undergoing treatment. In a non-limiting example, the diameter of the valve is reduced by a certain amount and the tension member is secured in place by a locking component. A test may then be performed to determine the functional level of the valve being treated. If the function is not at the desired level, the tensioning member is unlocked by the locking component and then pulled and re-fixed in place. Thus, exemplary embodiments of the present invention allow the valve size to be progressively reduced over a relatively long period of time. In one embodiment, the patient may undergo additional surgery that further reduces the valve diameter by pulling on the tension member closer to the locking component.

  The clamping device of the present invention can be implemented on any of the four valves of the heart. Those skilled in the art will recognize that the various valves may require the implementation of a special clamping device on the valve itself, and the placement and delivery of the components is a unique characteristic of each of the four valves. It is better to change to compensate.

  FIG. 9 is a diagram illustrating an exemplary embodiment of a clamping device 900 according to the present invention implemented in an aortic valve 930. The tightening device 900 of the exemplary embodiment shown in FIG. 9 is mounted on the aortic annulus 905 of the aortic root 910. As shown in the exemplary embodiment of FIG. 9, the clamping device 900 has an anchoring component 915 that pierces the aortic annulus 905. A locking component 920 that pierces the aortic annulus 905 is provided substantially opposite the aortic annulus 905. In the illustrated embodiment, the tension member 925 is passed through the locking component 920 and then the tension member 925 is coupled to the engagement member of the anchoring component 915. Once the tension member 925 is coupled to the engagement member, the tension member 925 is advanced to reduce the distance between the anchoring component 915 and the locking component 920. Subsequently, the tension member 925 is secured in place by the locking component 920. As a result, the leaflets of the aortic valve can be more completely closed, and the function of the aortic valve 930 can be improved.

  FIG. 10 is a plan view showing an exemplary embodiment of a clamping device 1000 according to the present invention mounted on a meniscal valve 1020. The tightening device 1000 enabled by the present invention can be mounted on any of the meniscal valve, aortic valve, or pulmonary valve. As shown in FIG. 10, the anchoring component 1005 and the locking component 1010 are configured on the annulus of the meniscus valve such that the tension member 1015 traverses a portion of the meniscus valve 1020. Accordingly, when the tension member 1015 is advanced, the diameter of the meniscal valve 1020 is decreased.

  FIG. 11 is a plan view illustrating an exemplary embodiment of a clamping device 1100 according to the present invention mounted on a meniscal valve 1105. The tightening device 1100 shown in FIG. 11 has three sets of anchoring components, locking components, and tension members. Those skilled in the art will appreciate that the number of sets of these components and their implementation will vary depending on the particular heart valve to be treated and the particular valvular situation to be resolved. In some embodiments, heart valve dysfunction may be less severe, in which case the desired reduction in heart valve diameter is relatively small. In such embodiments, a limited set of components is employed in the clamping device. In other embodiments, it may be desirable for the valve to be highly symmetric, in which case multiple sets of components are arranged to achieve and maintain full symmetry of the actuation valve. The exemplary embodiment shown in FIG. 11 shows that a clamping device having three sets of locking components, anchoring components, and tension members is mounted on the meniscal valve. The arrangement of these three sets of components ensures a symmetrical reduction in the diameter of the meniscus and ensures improved function and operation of the meniscus.

  FIG. 12 is a diagram illustrating an exemplary embodiment of a clamping device 1200 according to the present invention mounted on a tricuspid valve 1205. The tightening device 1200 of the exemplary embodiment shown in FIG. 12 is mounted on the annulus 1230 of the tricuspid valve 1205. As shown in the exemplary embodiment of FIG. 12, the clamping device 1200 has two anchoring components 1210, 1215. Similar to the embodiment of the clamping device used for the mitral valve, the anchoring components 1210, 1215 suitable for the tricuspid valve 1205 can be delivered in a variety of different ways. For example, but not limitation, an anchoring component is delivered percutaneously through the catheter to the right ventricle 1220. Once the anchoring component 1215 has been delivered into the right ventricle 1220, the anchoring component 1215 is pierced through the annulus 1230 of the tricuspid valve 1205 and protrudes into the right atrium 1225. Alternatively, the anchoring component 1215 may be delivered to the right atrium 1225 and then pierced through the annulus 1230 of the tricuspid valve 1205 to expose the anchoring component 1215 attachment member into the right ventricle 1220. Good.

  In addition to attaching the anchoring component between the annulus 1230 and the right ventricle 1220 of the tricuspid valve 1205, the anchoring component may be attached between the annulus 1230 and the wall of the right atrium 1225. As shown in FIG. 12, the anchoring component 1210 is mounted between the annulus 1230 of the tricuspid valve 1205 and the right atrium 1225. This method of attaching anchoring components allows additional delivery methods. For example, anchoring component 1210 is delivered and implanted via a long arm device. The surgeon implanting the anchoring component 1210 must be careful not to implant the anchoring component 1210 in the vicinity of an opening leading to the cardiac artery, eg, the opening 1235. Those skilled in the art will recognize that anchoring components may be delivered and implanted in a variety of different ways without departing from the scope of the present invention.

  The locking component 1240 may be provided generally on the opposite side of the annulus 1230 of the tricuspid valve 1205. In the illustrated embodiment, the locking component 11240 is delivered to the wall of the right atrium 1225 via a long arm device. The locking component 1240 is then pierced through the wall of the right atrium 1225. In the illustrated embodiment, the tension member 1245 is threaded through the locking component 1240 and the annulus 1230 of the tricuspid valve 1205. The tension member 1245 is then coupled to the engagement members of the anchoring components 1210, 1215. Once the tension member 1245 is coupled, the tension member 1245 is advanced to reduce the distance between the anchoring components 1210, 1215 and the locking component 1240. Subsequently, the tension member 1245 is secured in place by the locking component 1240. Thereby, the function of the tricuspid valve 1205 is improved by closing the leaflets of the tricuspid valve 1205 more completely.

  FIG. 13 is a plan view illustrating an exemplary embodiment of a clamping device 1300 according to the present invention mounted on a tricuspid valve 1205. As shown in FIG. 13, the tightening device 1300 has two sets of locking components, anchoring components, and tension members. Often, an incomplete tricuspid valve is improved by reducing the diameter of the tricuspid valve in several directions such that the junction of the three leaflets of the tricuspid valve 1205 becomes substantially irregular To do.

  As shown in FIG. 13, the anchoring component 1305 is placed on the side of the annulus of the tricuspid valve 1205 on the side close to the mitral valve. Next, on substantially the opposite side of the annulus, anchoring component 1305 is coupled to locking component 1310 by tension member 1315. In addition, anchoring component 1320 is positioned on the side of the annulus close to the aortic valve. Similarly, the anchoring component 1320 is coupled to the locking component 1325 by the tension member 1330 of the tricuspid valve 1205 at approximately the opposite side of the annulus. Advancement of the tension members 1315, 1330 reduces the diameter of the tricuspid valve 1205. Therefore, the leaflets of the tricuspid valve 1205 can be more completely closed, and the function of the tricuspid valve 1205 can be improved.

  While the invention has been disclosed in a preferred form, many modifications, additions and deletions have been made to the invention without departing from the spirit and spirit of the invention as set forth in the appended claims and equivalents thereof. It will be apparent to those skilled in the art that this is possible.

It is a figure which shows the normal mitral valve 101. FIG. It is a figure which shows the conventional valve correction apparatus currently disclosed by the prior art. 1 shows a conventional device used to perform a septal-side annulus tightening procedure (SLAC) disclosed in the prior art. FIG. FIG. 6A illustrates an exemplary embodiment 400A of an anchoring component according to the present invention. FIG. 6C shows a modified embodiment 400B of an anchoring component according to the present invention. FIG. 6 shows an exemplary embodiment of an engagement member 505 as a fixture prior to placement in accordance with the present invention. FIG. 6 illustrates an exemplary embodiment 605 of a locking component according to the present invention. FIG. 7 shows a modified embodiment 605 of the locking component according to the invention. FIG. 8 shows an exemplary embodiment 705 of an anchoring component according to the present invention. FIG. 8 shows an exemplary embodiment 800 of a clamping device according to the present invention. FIG. 8 shows an exemplary embodiment 900 of a clamping device implemented in an aortic valve 930 according to the present invention. 1 is a plan view illustrating an exemplary embodiment of a tightening device mounted on a half-moon valve according to the present invention. FIG. 1 is a plan view illustrating an exemplary embodiment of a tightening device mounted on a half-moon valve according to the present invention. FIG. FIG. 12 shows an exemplary embodiment 1200 of a clamping device implemented on a tricuspid valve 1205 in accordance with the present invention. FIG. 49 is a plan view illustrating an exemplary embodiment 1300 of a tightening device mounted on a tricuspid valve 1205 in accordance with the present invention.

Claims (41)

A method for improving the tissue morphology of a heart valve, comprising:
Attaching an anchoring component to a first target site on a cardiac tissue component;
Attaching a locking component to a second target site on the cardiac tissue component;
Connecting the tension member to the anchoring component;
Connecting the tension member to a locking component;
Adjusting the distance between the first target site and the second target site by actuating the tension member;
Using the locking component to secure the tension member in place.   The method of improving heart valve tissue morphology of claim 1, wherein the locking component is capable of performing a locking and unlocking operation. Releasing the tension member from the lock component by unlocking; and
Further adjusting the distance between the first portion and the second portion by advancing the tension member;
3. The method of improving heart valve tissue morphology of claim 2, further comprising securing the tension member using the locking component.   The heart of claim 1, wherein the step of adjusting a tension member includes reducing the distance between the first target site and the second target site by actuating and advancing the tension member. A method for improving the tissue morphology of a valve.   The method of improving heart valve tissue morphology of claim 1, wherein the step of attaching an anchoring component to a first target site is performed using a catheter.   The method of improving heart valve tissue morphology of claim 1, wherein the step of attaching a locking component to a second target site is performed using a long arm device.   The method of improving heart valve tissue morphology of claim 1, wherein the step of adjusting the distance between the first target site and the second target site by actuating a tension member is performed from outside the patient's body. .   2. The method of improving heart valve tissue morphology of claim 1, wherein the step of adjusting the distance between the first target site and the second target site is performed utilizing an approach that minimizes open blood. .   The method for improving heart valve tissue morphology of claim 1, wherein the step of locking the tension member using a locking component is performed from outside the patient's body.   The method of improving heart valve tissue morphology of claim 1, wherein the first target site is located in the posterior mitral annulus of the heart.   The method of improving heart valve tissue morphology of claim 1, wherein the second target site is located in the anterior mitral annulus of the heart.   The method of improving heart valve tissue morphology of claim 1, wherein the first target site is located in the aortic annulus of the aortic valve of the heart.   2. The method of improving heart valve tissue morphology of claim 1, wherein the second target site is located in the aortic annulus of the heart aortic valve.   The method for improving heart valve tissue morphology of claim 1, wherein the first target site is located in the annulus of a tricuspid valve of the heart.   2. The method of improving heart valve tissue morphology of claim 1, wherein the second target site is located in a tricuspid valve annulus of the heart.   The method of improving heart valve tissue morphology of claim 1, wherein the one target site is located in an annulus of a pulmonary valve of the heart.   The method of improving heart valve tissue morphology of claim 1, wherein the two target sites are located in the annulus of the pulmonary valve of the heart. A clamping device,
A proximal end having an attachment member connectable to a cardiac tissue component and an anchoring component having a distal end;
A locking component having an attachment member connectable to a cardiac tissue component;
A tension member,
The anchoring component is positionable at a first target site of a cardiac tissue component, and the locking component is positionable at a second target site of a cardiac tissue component;
The tension member is coupled to both the anchoring component and the locking component and is actuated to adjust the distance between the first target site and the second target site, by the locking component Fastening device fixed.   The tension member moves the distance between the first target site and the second target site by advancing the tension member to reduce the distance between the first target site and the second target site. The clamping device according to claim 18, wherein the clamping device is actuated to adjust.   The clamping device according to claim 18, wherein the locking by the locking component is releasable.   21. The tightening device of claim 20, wherein the tension member is released from being secured by the locking component, further advanced, and re-secured by the locking component.   19. The tightening device of claim 18, wherein the first target site is located on a posterior mitral annulus and the second target site is located on an anterior mitral annulus.   23. The tightening device of claim 22, wherein the distance between the first target site and the second target site is a septum-side diameter.   The tightening device according to claim 18, wherein the first target site is located in the aortic annulus and the second target site is located in the aortic annulus.   19. The tightening device of claim 18, wherein the first target site and the second target site are located proximal to the junction of the cardiac sinus and aortic tube at the aortic root.   The tightening device according to claim 18, wherein the first target site and the second target site are located proximal to a pulmonary valve.   The tightening device according to claim 18, wherein the first target portion and the second target portion are located proximal to a tricuspid valve.   The clamping device of claim 18, wherein the anchoring component is deliverable within a blood vessel.   The clamping device of claim 18, wherein the locking component is deliverable using a long arm device.   The tightening device of claim 18, wherein the tension member is advanceable from outside the patient's body.   The clamping device of claim 18, wherein the locking component is operable from outside the patient's body. A method for improving the tissue morphology of a heart valve, comprising:
Attaching an anchoring component to a first target site on a cardiac tissue component, the anchoring component comprising an engagement member, and the method comprises:
Attaching a locking component to a second target site on the cardiac tissue component;
Passing a wire provided with an engaging distal end through the locking component;
Coupling the engagement distal end of the wire to the engagement member of the anchoring component;
Reducing the distance between the first target site and the second target site by advancing the wire;
Using the locking component to secure the wire in place.   33. The method of improving heart valve tissue morphology of claim 32, wherein the locking component is capable of performing a locking and unlocking operation. Unlocking and releasing the wire from the locking component;
Further reducing the distance between the first target site and the second target site by advancing the wire;
34. The method of improving heart valve tissue morphology of claim 33, further comprising securing the wire in place using the locking component.   33. The method for improving heart valve tissue morphology of claim 32, wherein the first target site is located on the posterior mitral annulus of the heart.   34. The method of improving heart valve tissue morphology of claim 32, wherein the second target site is located on the anterior mitral annulus of the heart. Septum-side annulus tightening device,
An anchoring component having a proximal end having an attachment member connectable to a cardiac tissue component and a distal end having an engagement member;
A locking component having an attachment member connectable to a cardiac tissue component;
A wire having an engaging distal end,
The anchoring component is positionable at a first target site of a cardiac tissue component, and the locking component is positionable at a second target site of a cardiac tissue component;
The wire is threaded through the locking component and the engaging distal end of the wire is coupleable to the proximal end of the anchoring component;
The septal-side annulus tightening device, wherein the wire is advanceable to reduce the distance between the first target site and the second target site and can be secured by the locking component.   38. A septum-side annulus tightening device according to claim 37, wherein the locking by the locking component is releasable.   39. The septal-side annulus tightening device of claim 38, wherein the wire is released from being secured by the locking component, further advanced, and re-secured by the locking component.   38. The septal-side annulus tightening device of claim 37, wherein the annulus is a mitral annulus. A method for improving the tissue morphology of the heart valve is:
Attaching an anchoring component to the posterior mitral annulus of the heart, the anchoring component comprising an engagement member, the method comprising:
Attaching a locking component to the anterior mitral annulus of the heart;
Passing a tension member provided with an engaging distal end through the locking component;
Coupling the engagement distal end of the tension member to the engagement member of the anchoring component;
Reducing the distance between the posterior mitral annulus and the anterior mitral annulus by advancing the tension member;
Using the locking component to secure the tension member in place.

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